Versican Plus Pi

canine parainfluenza type-2 virus, strain CPiV-2 Bio 15 (live attenuated)

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This is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Versican Plus Pi?

Versican Plus Pi is a veterinary vaccine that contains live attenuated (weakened) canine parainfluenza virus type-2. Versican Plus Pi is available as a lyophilisate (freeze-dried pellet) with a solvent that are made up into a suspension for injection.

What is Versican Plus Pi used for?

Versican Plus Pi is used to protect dogs against canine parainfluenza virus, which causes kennel cough.

The vaccine is given to puppies from six weeks of age as an injection under the skin which is repeated three to four weeks later. For revaccination, a single dose of Versican Plus Pi is required annually.

How does Versican Plus Pi work?

Versican Plus Pi is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. The virus in Versican Plus Pi is alive but has been attenuated (weakened) so that does not cause disease. When Versican Plus Pi is given to dogs, the animals’ immune system recognises the viruses as ‘foreign’ and makes antibodies against them. In the future, if the animals are exposed to this infection, the immune system will be able to respond more quickly. This will help protect them against kennel cough.

How has Versican Plus Pi been studied?

The effectiveness of Versican Plus Pi was investigated in a field study involving 129 dogs. The field study involved the larger vaccine combinations Versican Plus DHPPi/L4 and Versican Plus DHPPi/L4R, which are also intended to protect against kennel cough in addition to other diseases, to demonstrate effectiveness of Versican Plus Pi. The dogs were either vaccinated twice with a three to four week interval or they received a single annual booster vaccination. The measure of effectiveness was levels of antibodies before and after vaccination.

What benefit has Versican Plus Pi shown during the studies?

The field study showed that vaccination with Versican Plus Pi resulted in protective levels of antibodies for parainfluenza virus ranging from 73 to 97%.

What is the risk associated with Versican Plus Pi?

The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus Pi is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.

Why has Versican Plus Pi been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus Pi exceed the risks for the approved indications and recommended that Versican Plus Pi be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Versican Plus Pi:

The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus Pi on 4 July 2014. Information on the prescription status of this product may be found on the label/outer package.

Name Language First published Last updated
Versican Plus Pi : EPAR - Summary for the public BG = bălgarski 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public ES = español 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public CS = čeština 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public DA = dansk 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public DE = Deutsch 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public ET = eesti keel 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public EL = elliniká 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public EN = English 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public FR = français 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public IT = italiano 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public LV = latviešu valoda 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public LT = lietuvių kalba 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public HU = magyar 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public MT = Malti 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public NL = Nederlands 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public PL = polski 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public PT = português 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public RO = română 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public SK = slovenčina 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public SL = slovenščina 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public FI = suomi 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public SV = svenska 2014-10-20  
Versican Plus Pi : EPAR - Summary for the public HR = Hrvatski 2014-10-20  

This EPAR was last updated on 10/04/2017 .

Authorisation details

Product details

Product details for Versican Plus Pi
NameVersican Plus Pi
Agency product numberEMEA/V/C/003681
Active substance

canine parainfluenza type-2 virus, strain CPiV-2 Bio 15 (live attenuated)

International non-proprietary name (INN) or common name

canine parainfluenza virus vaccine (live attenuated)

Species Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes QI07AD08


Publication details

Publication details for Versican Plus Pi
Marketing-authorisation holder

Zoetis Belgium SA

Revision2
Date of issue of marketing authorisation valid throughout the European Union04/07/2014

Contact address:

Zoetis Belgium SA
Rue Laid Burnait, 1
1348 Louvain-la-Neuve 
Belgium

Product information

Product information

23/03/2017  Versican Plus Pi -EMEA/V/C/003681 -IG/0747

Name Language First published Last updated
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10
Versican Plus Pi : EPAR - Product Information HR = Hrvatski 2014-10-20 2017-04-10

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  
Versican Plus Pi : EPAR - All Authorised presentations HR = Hrvatski 2014-10-20  

Pharmacotherapeutic group

Immunologicals for canidae, live viral vaccines

Therapeutic indication

Active immunisation of dogs from six weeks of age to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Versican Plus Pi : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2016-09-26 2017-04-10

Initial marketing-authorisation documents

Name Language First published Last updated
Versican Plus Pi : EPAR - Public assessment report HR = Hrvatski 2014-10-20  
CVMP summary of positive opinion for Versican Plus Pi HR = Hrvatski 2014-05-12